New guidance documents and regulatory amendments regarding therapeutic product shortages

As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and 2021. In anticipation of the expiry of Interim Order No. 2, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were promulgated in 2021, with some provisions set to come into force later. Health Canada has issued a Notice regarding the Regulations, which includes an explanation of how the amendments differ from the previous now-expired interim orders.

On March 2, 2022, provisions of the Regulations regarding the following subjects, among others, came into force:

• exceptional importation and sale of drugs and medical devices
• amendment to the Certificate of Supplementary Protection Regulations (to carve-out from the definition of “authorization for sale” permission to sell a drug under the Regulations)
• mandatory reporting of shortages and discontinuations of specified medical devices and the power to compel information on medical device shortages

Health Canada has announced a new guidance for drugs: Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148). All products on the List of drugs for exceptional importation and sale, including existing products, will now have an end of importation date, but are allowed to be sold in Canada until the product expires.

Health Canada has also released related guidance documents for medical devices:

• Guide to reporting medical device shortages and discontinuations
• Guidance for exceptional importation and sale of medical devices